At a glance
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A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Carboplatin, and 3 other interventions for Carcinoma. Completed, enrolled 289 participants across 21 sites.
Detailed Summary
This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.
Study Details
Timeline
Interventions
175 mg/m2, 1-3 hour IV infusion Day 1
AUC 6.0 IV Day 1
15 mg/kg IV infusion Day 1
150 mg PO
Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy